Modern-day Snake Oil Needs Oversight

July 09, 2000|By Henry I. Miller. Henry I. Miller, a physician, is a senior research fellow at Stanford University's Hoover Institution. He was an official at the Food and Drug Administration from 1979-94.

Herbal dietary supplements are big business in the United States. Americans spend $5 billion annually and the market is growing by 18 percent a year.

A third of Americans use herbal supplements--or botanicals, as they are correctly called--to treat everything from colds to depression.

As the products have gained popularity, botanicals most Americans had never even heard of a decade ago have become widely available. Echinacea, ginseng and St. John's wort, for example, are now sold in supermarkets, pharmacies and discount stores. More exotic botanicals, meanwhile, can be purchased at health food stores, specialty shops, through catalogs and the Internet.

But these ubiquitous products pose a threat to public health reminiscent of 19th Century snake-oil preparations. Many are known to be toxic, carcinogenic or otherwise dangerous. Serious known side effects include blood-clotting abnormalities, high blood pressure, life-threatening allergic reactions, cardiac arrhythmias, liver failure and exacerbation of autoimmune diseases. The American Society of Anesthesiologists has warned patients to stop taking herbal supplements at least two weeks before any scheduled surgery in order to avoid dangerous interactions with the drugs used for anesthesia.

In February, articles in the medical journal The Lancet identified important side effects of St. John's Wort: interference with the protease inhibitor indinavir, which can lead to treatment failure in AIDS patients; and rejection of heart transplants caused by an interaction with the immune suppressant cyclosporine.

Shouldn't these documented health threats to millions of Americans be addressed by federal food and drug regulation? Evidently not, according to our government. Congress virtually exempted these products from regulation under the 1994 Dietary Supplement Health and Education Act, which prevents federal regulators from requiring assurance that botanicals are either safe or effective, that the information about dosage on the label is correct, or even that the substance named on the label will actually be in the container. And in a regulation that went into effect earlier this year, the FDA worsened the situation by freeing supplement manufacturers to make all manner of dubious health claims--that their products treat conditions such as premenstrual syndrome and acne, for example, although only a few botanicals have been shown to be at all efficacious.

Regulation of the herbal supplement industry is so lax, and some of the products are so dangerous, that a public health catastrophe seems inevitable. It could take the form of a flurry of cases of organ failure or death in healthy people from ingesting an intrinsically toxic product, or one that contains far more active ingredients than is indicated on the label, or from a highly toxic additive.

Historically, there has been societal overreaction to such occurrences. The beginnings of our repressive federal system of drug regulation date to 1938, when Congress reacted to an incident in which diethylene glycol, a potent poison, was used as a solvent for an antibiotic and killed more than a hundred people within a few days. If a similar, high-profile problem were to occur with botanicals, Congress would likely reclassify them as drugs in response to the ensuing public and media outcry.

That would be calamitous for supplement manufacturers: Development, testing and Food and Drug Administration marketing approval of the average new drug requires 12 to 15 years and costs upwards of $500 million. Reclassifying botanicals as drugs would effectively spell the demise of the goose that is laying multibillion dollar eggs, and the end of consumers' access to a wide array of non-traditional medicines.

A better option would be voluntary oversight by an independent but non-governmental regulator. Models for such a mechanism already exist.

One example is the Nationally Recognized Testing Laboratories the prototype of which is Underwriters Laboratories, a large, non-profit organization that tests and certifies a wide spectrum of products, many of which present inherent potential hazards. The NRTLs use hundreds of discrete standards to certify product safety and charge a fee based on the cost of developing standards and testing.

Another existing model is the group of organizations that certify plants seeds sold to agricultural producers or growers, in order to prevent any compromise of seed quality or consistency. In California, for example, oversight is performed by the non-profit California Crop Improvement Association, which provides a voluntary quality assurance program for the maintenance and increase of crop seed. Each variety that enters this program is evaluated for its unique characteristics, such as pest resistance, adaptability, uniformity, quality and yield.